Trial Outcomes & Findings for Safety and Efficacy of Iron Sucrose in Children (NCT NCT00239642)
NCT ID: NCT00239642
Last Updated: 2021-11-17
Results Overview
Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
141 participants
Primary outcome timeframe
baseline through week 12
Results posted on
2021-11-17
Participant Flow
Hospitals and Medical Clinics; Study Period - October 24, 2005 through January 23, 2009
Stable erythropoietin (EPO) dose (±25% of current dose) for 8 weeks prior to the qualifying screening visit.
Participant milestones
| Measure |
Venofer (0.5 mg/kg)
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (1.0 mg/kg)
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (2.0 mg/kg)
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
47
|
49
|
|
Overall Study
COMPLETED
|
47
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Iron Sucrose in Children
Baseline characteristics by cohort
| Measure |
Venofer (0.5 mg/kg)
n=49 Participants
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (1.0 mg/kg)
n=47 Participants
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (2.0 mg/kg)
n=49 Participants
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
44 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
13.8 years
STANDARD_DEVIATION 4.40 • n=5 Participants
|
13.1 years
STANDARD_DEVIATION 4.62 • n=7 Participants
|
13.1 years
STANDARD_DEVIATION 4.87 • n=5 Participants
|
13.3 years
STANDARD_DEVIATION 4.64 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
31 participants
n=7 Participants
|
25 participants
n=5 Participants
|
82 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
23 participants
n=5 Participants
|
16 participants
n=7 Participants
|
24 participants
n=5 Participants
|
63 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline through week 12Population: Safety Population - Subjects who received at least 1 dose of study drug.
Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm
Outcome measures
| Measure |
Venofer (0.5 mg/kg)
n=47 Participants
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (1.0 mg/kg)
n=47 Participants
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (2.0 mg/kg)
n=47 Participants
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
|---|---|---|---|
|
Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event
|
27 participants
|
25 participants
|
26 participants
|
SECONDARY outcome
Timeframe: anytime during the 12 week post-baseline periodPopulation: mITT subjects
Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose)
Outcome measures
| Measure |
Venofer (0.5 mg/kg)
n=46 Participants
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (1.0 mg/kg)
n=45 Participants
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (2.0 mg/kg)
n=40 Participants
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
|---|---|---|---|
|
Number of Subjects Achieving Clinical Success
|
44 participants
|
40 participants
|
33 participants
|
SECONDARY outcome
Timeframe: anytime during the 12 week post-baseline periodPopulation: mITT subjects
Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose)
Outcome measures
| Measure |
Venofer (0.5 mg/kg)
n=46 Participants
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (1.0 mg/kg)
n=45 Participants
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (2.0 mg/kg)
n=40 Participants
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
|---|---|---|---|
|
Percentage (%) of Subjects Achieving Clinical Success
|
95.7 percentage of subjects
|
88.9 percentage of subjects
|
82.5 percentage of subjects
|
SECONDARY outcome
Timeframe: anytime during the 12-week post-baseline periodPopulation: mITT subjects
Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive
Outcome measures
| Measure |
Venofer (0.5 mg/kg)
n=46 Participants
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (1.0 mg/kg)
n=45 Participants
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (2.0 mg/kg)
n=40 Participants
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
|---|---|---|---|
|
Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
|
46 participants
|
43 participants
|
38 participants
|
SECONDARY outcome
Timeframe: anytime during the 12 week post-baseline periodPopulation: mITT subjects
Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Outcome measures
| Measure |
Venofer (0.5 mg/kg)
n=46 Participants
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (1.0 mg/kg)
n=45 Participants
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (2.0 mg/kg)
n=40 Participants
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
|---|---|---|---|
|
Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
|
100.0 percentage of subjects
|
95.6 percentage of subjects
|
95.0 percentage of subjects
|
SECONDARY outcome
Timeframe: anytime during the 12 week post-baseline periodPopulation: mITT subjects
Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive
Outcome measures
| Measure |
Venofer (0.5 mg/kg)
n=46 Participants
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (1.0 mg/kg)
n=45 Participants
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (2.0 mg/kg)
n=40 Participants
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
|---|---|---|---|
|
Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive
|
44 participants
|
42 participants
|
37 participants
|
SECONDARY outcome
Timeframe: anytime during the 12 week post-baseline periodPopulation: mITT subjects
Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive
Outcome measures
| Measure |
Venofer (0.5 mg/kg)
n=46 Participants
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (1.0 mg/kg)
n=45 Participants
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (2.0 mg/kg)
n=40 Participants
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
|---|---|---|---|
|
Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive
|
95.7 percentage of subjects
|
93.3 percentage of subjects
|
92.5 percentage of subjects
|
SECONDARY outcome
Timeframe: anytime during the 12 week post-baseline periodPopulation: mITT subjects
Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease \>25% in EPO dose from Baseline
Outcome measures
| Measure |
Venofer (0.5 mg/kg)
n=46 Participants
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (1.0 mg/kg)
n=45 Participants
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (2.0 mg/kg)
n=40 Participants
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
|---|---|---|---|
|
Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline
|
46 participants
|
45 participants
|
39 participants
|
SECONDARY outcome
Timeframe: anytime during the 12 week post-baseline periodPopulation: mITT subjects
Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease \>25% in EPO Dose from Baseline
Outcome measures
| Measure |
Venofer (0.5 mg/kg)
n=46 Participants
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (1.0 mg/kg)
n=45 Participants
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (2.0 mg/kg)
n=40 Participants
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
|---|---|---|---|
|
Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline
|
100.0 percentage of subjects
|
100.0 percentage of subjects
|
97.5 percentage of subjects
|
Adverse Events
Venofer (0.5 mg/kg)
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Venofer (1.0 mg/kg)
Serious events: 10 serious events
Other events: 15 other events
Deaths: 0 deaths
Venofer (2.0 mg/kg)
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Venofer (0.5 mg/kg)
n=47 participants at risk
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (1.0 mg/kg)
n=47 participants at risk
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (2.0 mg/kg)
n=47 participants at risk
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 2 • 3 years and 10 months
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/47 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/47 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/47 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/47 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/47 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
4.3%
2/47 • Number of events 3 • 3 years and 10 months
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/47 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/47 • 3 years and 10 months
|
6.4%
3/47 • Number of events 3 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
|
General disorders
Pyrexia
|
0.00%
0/47 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
|
Surgical and medical procedures
Renal Transplant
|
6.4%
3/47 • Number of events 3 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/47 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/47 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
2.1%
1/47 • Number of events 1 • 3 years and 10 months
|
Other adverse events
| Measure |
Venofer (0.5 mg/kg)
n=47 participants at risk
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (1.0 mg/kg)
n=47 participants at risk
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
Venofer (2.0 mg/kg)
n=47 participants at risk
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
|---|---|---|---|
|
Investigations
Blood pressure increased
|
4.3%
2/47 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
6.4%
3/47 • 3 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
1/47 • 3 years and 10 months
|
2.1%
1/47 • 3 years and 10 months
|
6.4%
3/47 • 3 years and 10 months
|
|
Nervous system disorders
Headache
|
4.3%
2/47 • 3 years and 10 months
|
8.5%
4/47 • 3 years and 10 months
|
4.3%
2/47 • 3 years and 10 months
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/47 • 3 years and 10 months
|
6.4%
3/47 • 3 years and 10 months
|
4.3%
2/47 • 3 years and 10 months
|
|
Surgical and medical procedures
Renal Transplant
|
6.4%
3/47 • 3 years and 10 months
|
2.1%
1/47 • 3 years and 10 months
|
2.1%
1/47 • 3 years and 10 months
|
|
Infections and infestations
Respiratory tract infection viral
|
8.5%
4/47 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
4.3%
2/47 • 3 years and 10 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/47 • 3 years and 10 months
|
6.4%
3/47 • 3 years and 10 months
|
0.00%
0/47 • 3 years and 10 months
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/47 • 3 years and 10 months
|
6.4%
3/47 • 3 years and 10 months
|
2.1%
1/47 • 3 years and 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60